DIN Standards Committee Medicine
NA 063-04-10 AA
Sterilization and processing of medical devices
The working committee is responsible for standardization in the fields of:
- requirements for medical devices to be designated as sterile;
- development, validation and routine control of sterilization processes and aseptic processing of medical devices;
- microbiological aspects of processes including sterility testing;
- aspects of the medical device manufacturer's responsibility with regard to the processing of medical devices;
- requirements for medical devices which apply at a level of microbiological contamination specified by the manufacturer.
The standardization work on sterilization processes applies to all sterilizing agents and sterilization processes.
The standardization work on cleaning- , disinfection and sterilization processes for use in health care facilities is carried out in cooperation with other working committees of NA 063-04 FB "Section for Sterilization, Disinfection, Sterile Supply", who also have established standards and guidelines on this topic.
The standardization work on sterilization processes with low-temperature steam formaldehyde is carried out by NA 063-04-02 AA "Low temperature sterilizers", since these processes are mainly used in health care facilities. The standardization work on aseptic processing is carried out in cooperation with the working committee NA 063-04-11 AA "Aseptic processing". The focus of the standardization work of NA 063-04-11 AA is on aseptic processing of pharmaceuticals.
The standardization work on washer-disinfectors is carried out by NA 063-04-09 AA "Washer-disinfectors", since these processes are mainly used in health care facilities and these standards define target parameters for cleaning and disinfection performance for such procedures in the health care sector.
Ensuring a low microbial contamination condition of medical devices only applies to medical devices that shall be intended to apply with a microbiological contamination level specified by the manufacturer (but not on non-sterile delivered medical devices which have to be processed before use).